The Federal Trade Commission decides not to pursue investigations into health claims substantiation for Prestige Brands' Chloraseptic Defense Daily Health Strips and Insight Pharmaceuticals' Sucrets Defense lozenges in part because both products have been permanently discontinued, FTC states in June 1 letters to the companies. The Chloraseptic Defense strips claimed to boost the immune system and prevent flu and cold. Similarly, Sucrets Defense claimed to boost the immune system and fight colds as well as provide protection before entering crowded places. Other factors leading to FTC's decisions to not pursue the investigations include the short periods of time the products were marketed, the limited nature of the products' ad campaigns and relatively small resulting sales, FTC states...
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Advanz Pharma would have had to show that the European Commission’s decision to revoke Ocaliva’s conditional marketing approval risked causing serious and irreparable harm, according to lawyers from Van Bael & Bellis.
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A new pilot aims to take Brazil closer to ‘digital transformation.’
Clinical trial sponsors in the rare disease space face “big safety demands” from regulators, which can be challenging for those with limited resources. A CRO founder makes the case for “embedding automation” into the clinical trial process to keep pace with regulatory requirements.
The developers of the ChAdOx1 NipahB vaccine will be able to benefit from the early and enhanced support that the European Medicines Agency offers through its priority medicines scheme.
The termination of the HHS Secretary’s Committee on Human Research Protections closed an important forum for discussing pediatrics and pregnancy in clinical trial design, a former SACHRP chair said.
